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OpenTrials
Completed

NCT Number: NCT04073056

Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai St. Lukes Hospital

New York, 10025, United States

About this study

The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. Like the more commonly used transversus abdominis plane (TAP) block, the QL 2 block targets the anterior rami of T7-T12, ilioinguinal, iliohypogastric, and the lateral cutaneous branches of L1-L3. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery. Conventional therapy has consisted of surgical infiltration of the incision ports with bupivacaine 0.25%. The study team proposes a study to compare the analgesic effects of the QL 2 block with conventional therapy, consisting of surgical wound infiltration, for postoperative analgesia following laparoscopic gastric sleeve gastrectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy
  • 18-65 years of age
  • BMI> 35 kg/m2.

Exclusion criteria

  • Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
  • Contraindication/allergy to acetaminophen or ketorolac
  • History of substance abuse or chronic opioid use
  • Coagulopathy
  • Patients receiving systemic anticoagulation
  • Local infection
  • ASA 4

Treatment and study plan

Bupivacaine

Drug

Bupivacaine Hcl 0.25% Inj

Primary outcomes

  1. The Amount of Opioid Consumption During and After Procedure

    Time frame: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2

    The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)

Secondary outcomes

  1. VAS Pain Scores

    Time frame: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2

    Visual analogue scale - total score from 0 to 10, with higher score indicating more pain

  2. Respiratory Rate

    Time frame: 1 hour post op

    Respiratory rate in breaths per minute

  3. Heart Rate

    Time frame: 1 hour after surgery

    Heart rate in beats per minute

  4. Blood Pressure

    Time frame: 1 hour after surgery

    Both systolic and diastolic pressures

  5. Time to First Dose of Analgesic Request

    Time frame: up to 60 minutes

    Time until first analgesic request in minutes

  6. PACU Length of Stay

    Time frame: average 2 hours

    Post anesthesia care unit (PACU) length of stay in hours

  7. Number of Participants With Pain

    Time frame: Up to 48 hours

    Number of participants with somatic or visceral pain.

  8. Number of Participants With Nausea

    Time frame: the first 48 hours after the procedure

    Number of participants with nausea

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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